Details for New Drug Application (NDA): 020753
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The generic ingredient in AROMASIN is exemestane. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the exemestane profile page.
Summary for 020753
| Tradename: | AROMASIN |
| Applicant: | Pfizer |
| Ingredient: | exemestane |
| Patents: | 0 |
Pharmacology for NDA: 020753
| Mechanism of Action | Aromatase Inhibitors |
Suppliers and Packaging for NDA: 020753
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AROMASIN | exemestane | TABLET;ORAL | 020753 | NDA | Pharmacia & Upjohn Company LLC | 0009-7663 | 0009-7663-04 | 30 TABLET in 1 BOTTLE (0009-7663-04) |
| AROMASIN | exemestane | TABLET;ORAL | 020753 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-2858 | 59762-2858-1 | 30 TABLET, SUGAR COATED in 1 BOTTLE (59762-2858-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 21, 1999 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020753
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | AROMASIN | exemestane | TABLET;ORAL | 020753-001 | Oct 21, 1999 | 4,808,616 | ⤷ Get Started Free |
| Pfizer | AROMASIN | exemestane | TABLET;ORAL | 020753-001 | Oct 21, 1999 | 4,904,650 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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